*FINANCIAL DISCLAIMER: In support of their research for or
preparation of this work, one or more of the authors may have
received, in any one year, outside funding or grants from Biomet,
EBI, LLC or Biolectron, Inc.

INDICATIONS The Biomet® SpinalPak® Non-invasive
Spine Fusion Stimulator System is a noninvasive bone growth
stimulator indicated as an adjunct electrical treatment to primary
lumbar spinal fusion surgery for one or two levels. -
P850022/S017.

USAGE Federal Law
(U.S.A.) restricts this device to sale by or on the order of a
physician. Rx Only - Prescription Only - Single Patient Use Only -
Do Not Reuse.

Wang Z, Clark CC, and
Brighton CT. Up-Regulation of Bone Morphogenetic Proteins in
Cultured Murine Bone Cells with Use of Specific Electric Fields. J.
Bone Joint Surg Am. 88:1053-1065, 2006. Following non invasive
electrical stimulation, increases in multiple growth factors have
been observed in various pre-clinical in vitro cellular and in vivo
animal studies. Although not indicative of human clinical results,
these factors have been implicated in various models of bone
repair.*

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